GUEST COLUMNISTS

• What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI

  The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

• How Is Your Glass Supplier Adapting To Europe's Energy Crisis?

  Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.

• The EU Overhauls Pharma Laws: What You Need To Know

  On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.

• September 2026 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?

  FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

• Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty

  Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

• Is Your Supply Chain Ready For The End Of Class VI?

  Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

• Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs

  Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.